Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Hongkou District, Shanghai, 200000, China.
Shanghai University of Traditional Chinese Medicine, 1200 Cailun Road, Pudong New District, Shanghai, 200000, China.
Trials. 2020 Nov 4;21(1):910. doi: 10.1186/s13063-020-04807-z.
Practitioners of complementary and alternative medicine have suggested that electroacupuncture (EA) could improve post-stroke cognitive impairment, based on the clinical evidence. This study protocol is aimed at showing the effectiveness of theta and gamma EA for post-stroke patients on working memory (WM) and electrophysiology.
After assessing their eligibility, 66 patients with stroke will be enrolled from two Chinese medicine hospitals and randomly divided into theta frequency EA group, gamma frequency EA group, and sham-EA group according to the ratio of 1:1:1. All patients will receive 20 sessions of EA procedures for 4 weeks. Patients in three groups will receive EA at two same acupoints in the head: Baihui (GV20) and Shenting (GV24). The frequency of the three groups of EA is set as follows: 6 Hz (theta-EA group), 40 Hz (gamma-EA group), and no current through the electrodes (sham EA). Patients and assessors will be blinded throughout the entire study. The primary outcome is the performance accuracy of 1-back task which is a frequently used measure of WM in cognitive neuroscience research contexts. Secondary outcome measures will include the response time of 1-back task, the Rivermead Behavioral Memory Test, Trail Making Test, Loewenstein Occupational Therapy Cognitive Assessment Scale, modified Barthel Index, and electroencephalogram (EEG) signals during 1-back tasks. A blinding index will be assessed. Data will be statistically analyzed by one-way ANOVA, at 5% of significance level.
We expect this double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial to explore the effectiveness of theta and gamma EA therapy, compared with sham EA, for post-stroke WM.
Chinese Clinical Trial Registry, ChiCTR2000031995 . Registered on 17 April 2020.
基于临床证据，补充和替代医学从业者提出电针（EA）可能改善中风后认知障碍。本研究方案旨在展示θ和γ EA 对中风后患者工作记忆（WM）和电生理学的有效性。
在评估其合格性后，将从两家中医院招募 66 名中风患者，并按照 1:1:1 的比例随机分为θ频率 EA 组、γ频率 EA 组和假 EA 组。所有患者将接受 20 次 4 周的 EA 治疗。三组患者均在头部两个相同穴位进行 EA：百会（GV20）和神庭（GV24）。三组 EA 的频率设置如下：6 Hz（θ-EA 组）、40 Hz（γ-EA 组）和电极无电流（假 EA 组）。患者和评估者在整个研究过程中均处于盲态。主要结局是 1 -back 任务的表现准确性，这是认知神经科学研究中常用的 WM 测量方法。次要结局指标包括 1 -back 任务的反应时间、Rivermead 行为记忆测试、连线测试、Loewenstein 职业治疗认知评估量表、改良巴氏指数和 1-back 任务期间的脑电图（EEG）信号。将评估盲法指数。数据将采用单因素方差分析进行统计分析，显著性水平为 5%。
我们预计这项双中心、随机、患者和评估者盲法、假对照、平行、临床试验将探索与假 EA 相比，θ 和γ EA 治疗对中风后 WM 的有效性。
中国临床试验注册中心，ChiCTR2000031995。于 2020 年 4 月 17 日注册。
